BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT 100

    MDR report key: 19411238 · Received May 28, 2024

    Report

    Report Number
    3013398957-2024-12077
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    PARAGON VISION SCIENCES, INC.
    Product Code
    NUU
    PMA / PMN Number
    P870024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS WAS NOT RETURNED FOR FURTHER INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE QUALITY CONTROL (QC) BATCH MET RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE. THE DEVICE DID NOT CAUSE A DEATH OR LIFE-THREATENING INJURY AND THERE WAS NO PERMANENT IMPACT TO VISUAL ACUITY.

    Description of Event or Problem · 0

    PATIENT HAD ULCER DEVELOP IN OD. DR DISCONTINUED LENS WEAR AND PRESCRIBED TOBRAMYCIN DROPS. SAW PATIENT BACK IN A WEEK AND CORNEA WAS COMPLETELY HEALED. WILL HAVE PATIENT DISCONTINUE LENSES A FEW MORE WEEKS TO GET BACK TO BASELINE AND THEN CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593201 PARAGON CRT 100 ORTHOKERATOLOGY LENSES NUU PARAGON VISION SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention